EN ISO 11073-10101:2005/A1:2017

SLOVENSKI STANDARD
01-februar-2018
Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe –
10101. del: Nomenklatura (ISO/IEEE 11073-10101:2004/Amd 1:2017)
Health informatics - Point-of-care medical device communication - Part 10101:
Nomenclature - Amendment 1: Additional definitions (ISO/IEEE 11073-10101:2004/Amd
1:2017)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
10101: Nomenklatur - Änderung (ISO/IEEE 11073-10101:2004/Amd 1:2017)
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -
Partie 10101: Nomenclature - Amendement 1 (ISO/IEEE 11073-10101:2004/Amd
1:2017)
Ta slovenski standard je istoveten z: EN ISO 11073-10101:2005/A1:2017
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11073-
EUROPEAN STANDARD
10101:2005/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2017
ICS 01.040.35; 35.240.80
English Version
Health informatics - Point-of-care medical device
communication - Part 10101: Nomenclature - Amendment
1: Additional definitions (ISO/IEEE 11073-
10101:2004/Amd 1:2017)
Informatique de santé - Communication entre Medizinische Informatik - Kommunikation
dispositifs médicaux sur le site des soins - Partie patientennaher medizinischer Geräte - Teil 10101:
10101: Nomenclature - Amendement 1 (ISO/IEEE Nomenklatur - Änderung 1 (ISO/IEEE 11073-
11073-10101:2004/Amd 1:2017) 10101:2004/Amd 1:2017)
This amendment A1 modifies the European Standard EN ISO 11073-10101:2005; it was approved by CEN on 13 April 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10101:2005/A1:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 11073-10101:2005/A1:2017) has been prepared by Technical Committee
ISO/TC 215 “Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health
informatics” the secretariat of which is held by NEN.
This Amendment to the European Standard EN ISO 11073-10101:2005 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by May
2018, and conflicting national standards shall be withdrawn at the latest by May 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10101:2004/Amd1:2017 has been approved by CEN as EN ISO 11073-
10101:2005/A1:2017 without any modification.

INTERNATIONAL ISO/IEEE
STANDARD 11073-10101
First edition
2004‐12‐15
AMENDMENT 1
2017‐10
Health informatics — Point-of-care medical
device communication —
Part 10101:
Nomenclature
AMENDMENT 1: Additional definitions
Informatique de santé — Communication entre dispositifs médicaux sur le
site des soins —
Partie 10101: Nomenclature
AMENDEMENT 1: Définitions supplementaires
Reference number
ISO/IEEE 11073‐10101:2004/Amd 1:2017(E)
©
IEEE 2015
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
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ii © IEEE 2015 – All rights reserved

ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Foreword
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ISO or the IEEE Standards Association.
Amendment 1 to ISO/IEEE 11073‐10101:2004/Amd 1:2017 was prepared by the 11073 Committee of the
Engineering in Medicine and Biology Society of the IEEE (as IEEE 11073‐10101:2004). It was adopted by
Technical Committee ISO/TC 215, Health informatics, in parallel with its approval by the ISO/IEC national
bodies, under the “fast‐track procedure” defined in the Partner Standards Development Organization
cooperation agreement between ISO and IEEE. IEEE is responsible for the maintenance of this document with
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© IEEE 2015 – All rights reserved iii

IEEE Std 11073-10101a™-2015
(Amendment to
ISO/IEEE 11073-10101:2004)
Health informatics—Point-of-care medical device communication
Part 10101: Nomenclature
Amendment 1: Additional Definitions
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 5 December 2015
IEEE-SA Standards Board
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC)
medical device communication (MDC), the nomenclature defined by the base ISO/IEEE 11073-
10101:2004 nomenclature standard is extended by this amendment. Significant extensions to
support haemodynamics, respiration, ventilation and anesthesia monitoring, blood gas, urine,
fluid-related metrics, and neurology, as well as units of measurements and measurement sites,
are included. Formal definitions for observation identifiers used by the IEEE 11073 Personal
Health Device standards and additional attributes for reporting their regulatory and certification
status are also captured and provided. Information attributes to support alert communication and
accurate medical device time synchronization and timekeeping are also defined.
Keywords: alert communication, anesthesia, blood gas, codes, Continua, fluid-related metrics,
haemodynamics, IEEE 11073-10101a, IHE PCD, information model, ISO/IEEE 11073-10101,
measurement sites, medical device certification, medical device communication, neurology,
nomenclature, NTP, ontology, patient, PCHA, Personal Connected Health Alliance, POC, point-
of-care, respiration, semantics, service model, terminology, time synchronization, timekeeping,
units of measure, urine, ventilation
xx
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of the publisher.
vi
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
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vii
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
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viii
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
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ix
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Participants
At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Upper Layers
Working Group had the following membership:
Jan Wittenber, Chair
Paul Schluter and Todd Cooper, Vice Chairs
Malcolm Clarke Norman Jones Stefan Schlichting
Steven Dain Kenneth Marks John Walsh
Kenneth Fuchs John Rhoads Daidi Zhong
Jeff Rinda
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Susan Burgess Werner Hoelzl Stefan Schlichting
Keith Chow Noriyuki Ikeuchi Paul Schluter
Malcolm Clarke Atsushi Ito Janek Schumann
Gion Durisch Piotr Karocki Eugene Stoudenmire
Christoph Fischer Daniel Kraehenbuehl Walter Struppler
Kenneth Fuchs Kenneth Marks John Walsh
John Garguilo Melvin Reynolds J. Wiley
Joel Goergen John Rhoads Jan Wittenber
Randall Groves Bartien Sayogo Oren Yuen
Kai Hassing Daidi Zhong
When the IEEE-SA Standards Board approved this standard on 5 December 2015, it had the following
membership:
John D. Kulick, Chair
Jon Walter Rosdahl, Vice Chair
Richard H. Hulett, Past Chair
Konstantinos Karachalios, Secretary
Masayuki Ariyoshi Joseph L. Koepfinger* Stephen J. Shellhammer
Ted Burse David J. Law Adrian P. Stephens
Stephen Dukes Hung Ling Yatin Trivedi
Jean-Philippe Faure Andrew Myles Phillip Winston
J. Travis Griffith T. W. Olsen Don Wright
Gary Hoffman Glenn Parsons Yu Yuan
Michael Janezic Ronald C. Petersen Daidi Zhong
Annette D. Reilly
*Member Emeritus
x
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Introduction
This introduction is not part of IEEE Std 11073-10101a™-2015, Health informatics—Point-of-care medical device
communication—Part 10101: Nomenclature—Amendment 1: Additional Definitions.
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems.
They provide automatic and detailed electronic data capture of patient vital signs information and device
operational data. The primary goals are to:
 Provide real-time plug-and-play interoperability for patient-connected medical devices
 Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-
care, in all health care environments
This amendment extends the nomenclature originally defined by the base IEEE Std 11073-10101:2004
nomenclature standard. It reflects the continued innovation in medical device and system design for the
past decade and is based on a highly successful collaboration with the following organizations:
 Integrating the Healthcare Enterprise (IHE) Patient Care Devices (PCD) domain
 Personal Connected Health Alliance (PCHA, formerly Continua Health Alliance)
 ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee 4, Terminology and semantics
In addition, other vendors and standards development and profiling organizations have contributed to and
have recognized the value of this work and the benefit it provides to the user and provider communities and
to the patients that we ultimately serve.
This nomenclature amendment includes significant extensions to support:
 haemodynamics
 respiratory, ventilation and anesthesia monitoring
 blood gas, urine, fluid chemistry and other fluid-related metrics
 neurology
 units of measurements and measurement sites
 new medical device types, including infant warmers and incubators
This amendment also provides:
 formal definitions for observation identifiers used by IEEE 11073 Personal Health Devices
 attributes for reporting medical device regulatory and certification status
 attributes to support alert communication
 attributes to support accurate medical device time synchronization and timekeeping
NOTES as used in this amendment (preceding editorial instructions) are not meant to be included in the
rollup or part of the editorial instructions. They are used solely to provide informative guidance and
background to the reader as to why certain changes were made.
xi
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Contents
4. Terms and definitions . 2
5. Symbols (and abbreviated terms) . 2
Annex A (normative) Nomenclature semantics . 4
A.5 Nomenclature, data dictionary, and codes for vital signs devices (Block A) . 5
A.6 Terminology and codes for units of measurement (Block B) . 8
A.7 Nomenclature, data dictionary, and codes for metrics (measurements and enumerations)
(Block C) . 14
A.7.3 Nomenclature and codes for hemodynamic monitoring measurements . 14
A.7.4 Nomenclature and codes for respiratory, ventilator and anesthesia measurements . 17
A.7.4.18 Gas concentration and partial pressure measurements . 17
A.7.4.19 Inspiratory breath type classification. 18
A.7.4.20 Nomenclature and code table . 20
A.7.4.21 Nomenclature and codes for nebulizers . 59
A.7.5 Nomenclature, data dictionary, and codes for common blood-gas, blood, urine, and other
fluid chemistry measurements . 61
A.7.8 Nomenclature, data dictionary, and codes for neurological monitoring measurements . 64
A.7.11 Nomenclature and code extensions for miscellaneous measurements . 66
A.7.11.7 Body Weight and Surface Area . 67
A.7.12 Nomenclature and code extensions for infant incubator and warmer microenvironments . 67
A.7.13 Nomenclature and code extensions for personal health devices. 69
A.8 Nomenclature, data dictionary, and codes for body sites (Block D) . 72
A.8.1 Sites for EEG-electrode placement on the head . 72
A.11 Information attributes to support IHE PCD DEC and PCHA Continua WAN . 73
A.11.1 Information attributes to support IHE PCD Alert Communication Management . 73
A.11.2 Infrastructure attributes to support PCHA/Continua WAN and IHE PCD DEC . 73
A.11.3 Information attributes to support PCHA/Continua WAN . 74
A.11.4 Information attributes to support IHE PCD DEC and PCHA/Continua WAN
timekeeping . 75
A.11.5 Information attributes to support semantics defined by this standard . 77
Annex C (normative) Terms and codes . 78
C.1 Overview . 78
C.2 Discriminator sets . 78
C.3 Terms and discriminators . 80
Annex D (informative) Breaths and inflations . 97
Annex E (informative) Respiratory, ventilator, and anesthesia reference ID naming conventions . 98
Annex F (informative) Anesthesia ventilation and breathing circuits . 100
F.1 Bellows driven on expiratory side . 102
F.2 Piston driven on inspiratory side . 103
F.3 Mapleson circuits . 104
Annex G (informative) Bibliography . 105
xii
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Health informatics—Point-of-care medical device communication
Part 10101: Nomenclature
Amendment 1: Additional Definitions
IMPORTANT NOTICE: IEEE Standards documents are not intended to ensure safety, security, health,
or environmental protection, or ensure against interference with or from other devices or networks.
Implementers of IEEE Standards documents are responsible for determining and complying with all
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This IEEE document is made available for use subject to important notices and legal disclaimers. These
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NOTE—The editing instructions contained in this amendment define how to merge the material contained therein into
the existing base standard and its amendments to form the comprehensive standard.
The editing instructions are shown in bold italic. Four editing instructions are used: change, delete, insert, and replace.
Change is used to make corrections in existing text or tables. The editing instruction specifies the location of the
change and describes what is being changed by using strikethrough (to remove old material) and underscore (to add
new material). Delete removes existing material. Insert adds new material without disturbing the existing material.
Insertions may require renumbering. If so, renumbering instructions are given in the editing instruction. Replace is used
to make changes in figures or equations by removing the existing figure or equation and replacing it with a new one.
Editing instructions, change markings, and this NOTE will not be carried over into future editions because the changes
will be incorporated into the base standard.
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
IEEE Std 11073-10101a-2015
Health informatics—Point-of-care medical device communication—Part 10101: Nomenclature—
Amendment 1: Additional Definitions
4. Terms and definitions
Replace the boilerplate paragraph (and its footnote) with the following sentence as shown. Renumber
footnotes accordingly.
For the purposes of this document, the following terms and definitions apply. The IEEE Standards
Dictionary Online should be consulted for terms not defined in this clause.
Insert the following new terms and definitions in alphabetical order:
base term: A fundamental semantic concept.
co-constraint: A rule describing a constraint whose scope is inclusive of more than one term.
constraint: A restriction on the set of values being assigned.
discriminators: A mechanism to provide additional semantic refinement to multiple base terms.
domain information model (DIM): The model describing common concepts and relationships for a
problem domain.
electronic health records: A longitudinal collection of electronic health information about individual
patients or populations. It is a record in digital format that is capable of being shared within or across
different health care settings by being embedded in network-connected enterprise-wide information system.
reference ID (REFID): A unique, symbolic, and programmatic form for the term. The form is correlated
to the context-free code (i.e., terms are by definition context-free with respect to all other terms); in this
standard, terms are prefixed with “MDC_” for consistency.
systematic name: An organization of differentiating, relational descriptors that are unique for each term.
terminology: A synonym for nomenclature.
5. Symbols (and abbreviated terms)
Insert the following abbreviated terms into the existing list, in alphabetical order:
aka also known as
DIM domain information model
ECG electrocardiogram
HL7 Health Level Seven
ID identifier
IEEE Standards Dictionary Online subscription is available at:
http://www.ieee.org/portal/innovate/products/standard/standards_dictionary.html.
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
IEEE Std 11073-10101a-2015
Health informatics—Point-of-care medical device communication—Part 10101: Nomenclature—
Amendment 1: Additional Definitions
IHE PCD Integrating the Healthcare Enterprise Patient Care Devices
MDC Medical Device Communication
PCHA Personal Connected Health Alliance (formerly Continua Health Alliance)
PHD IEEE 11073 Personal Health Device series of communication standards, including the
IEEE Std 11073-20601 base standard and -104XX Device Specializations
REFID IEEE 11073 reference identifier
typ typical
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
IEEE Std 11073-10101a-2015
Health informatics—Point-of-care medical device communication—Part 10101: Nomenclature—
Amendment 1: Additional Definitions
Annex A
(normative)
Nomenclature semantics
[NOTES in this amendment are not meant to be included in the rollup or part of the editorial instructions. They are
used in this amendment solely to provide informative guidance and background to the reader as to why certain changes
were made.]
NOTE—This amendment extends the nomenclature defined by the base ISO/IEEE 11073-10101:2004 nomenclature
standard. It includes significant extensions to support haemodynamics, respiration, ventilation and anesthesia
monitoring, blood gas, urine, fluid-related metrics, and neurology, as well as specialized units of measurements and
measurement sites. It also captures and provides formal definitions for observation identifiers used by the IEEE 11073
Personal Health Device standards and additional attributes for reporting their regulatory and certification status.
The nomenclature extensions may be used in other persistent storage and communication standards [e.g., Health Level
Seven International (HL7) V2 and V3, and Digital Imaging and Communications in Medicine (DICOM)] for use by
various applications, including clinical information systems, electronic patient records, and clinical research.
These enterprise-facing communication standards require that the IEEE 11073 concept of a ‘partition’ and ‘code’ be
combined into a single 32-bit ‘context-free’ identifier, as part of a single Medical Device Communication (MDC)
vocabulary identifier. In this amendment, the combined partition and code information is listed in the ‘Part::Code’
column, augmenting the earlier context-sensitive ‘Code’ column. This also facilitates aggregation and processing of
medical device data defined in multiple IEEE 11073 partitions, such as advanced diagnostic electrocardiography,
implanted devices, and personal health devices.
All new terms defined by this amendment express the context-free Part::Code identifiers without braces. Existing
context-free from IEEE Std 11073-10101:2004 are enclosed in square braces [Part::Code] and ‘refid-synonyms’ are
enclosed in wavy braces {Part::Code} terms. The braces indicate substantial equivalency to existing Part::Code
identifiers and are used to identify terms that have been included for completeness or have been modified for clarity.
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
IEEE Std 11073-10101a-2015
Health informatics—Point-of-care medical device communication—Part 10101: Nomenclature—
Amendment 1: Additional Definitions
A.5 Nomenclature, data dictionary, and codes for vital signs devices (Block A)
A.5.7 Code table
NOTE—This table includes vital signs devices from Annex B of IEEE Std 11073-10101:2004 that were not defined in Annex A and new vital signs devices. It does not include
vital signs devices that were already defined in Annex A (codes 1::4100 to 1::4508, inclusive). All are assigned to the partition MDC_PART_OBJ (1).
Insert the following rows at the end of Table A.5.1 as shown:
Table A.5.1—Nomenclature and codes for vital signs devices (continued)
Systematic name Common term Description/Definition Reference ID Part::Code
Device | | | Generic device Generic device, may be used as placeholder. MDC_DEV 1::4096
Device, general | | | General device Generic device, of any type. MDC_DEV_GENERAL 1::5120
Device, auxiliary | | | Auxiliary device Generic device, of any type. MDC_DEV_AUX 1::5124
Device | ElectricalPotential, Respiration ECG-derived respiration Instrument for the indirect measurement of respiration MDC_DEV_ECG_RESP
| Lung, transthoracic impedance | rate by estimating transthoracic impedance using the 1::5128
ECG leads.
Device | ElectricalPotential | Heart, ECG arrhythmia Instrument for acquisition, analysis and detection of MDC_DEV_ARRHY
arrhythmia or conduction disturbance | cardiac arrhythmias or conduction disturbances. 1::5132

Device | Pressure | Haemodynamic | Haemodynamic pulse rate Instrument for acquisition, analysis and detection of MDC_DEV_PULS
1::5136
haemodynamic pulse rate and other information.
Device | ElectricalPotential | Heart, ST ECG ST Instrument for acquisition, analysis and detection of ST MDC_DEV_ST
deviation and cardiac repolarization | deviation and cardiac repolarization disturbances. 1::5140

Analyzer | Concentration | Airway, CO2 CO2 gas analyzer, capnometer, Instrument for the direct measurement of airway CO2 MDC_DEV_CO2
1::5144
| capnograph concentration and respiration rate.
Device | Pressure, non-invasive | Blood Non-invasive blood pressure Instrument for the non-invasive measurement of blood MDC_DEV_PRESS_BLD_NONINV
1::5148
| pressure.
Device | Flow, perfusion | Blood, Cerebral perfusion Instrument for the measurement of the level of blood MDC_DEV_CEREB_PERF
1::5152
cerebral | perfusion in cerebral tissue.
Device | Concentration or Continuous CO2 Instrument for the direct and continuous measurement MDC_DEV_CO2_CTS
PartialPressure, CO2 | Continuous | of CO2 concentration or partial pressure. 1::5156

Device | PartialPressure, pCO2 | Skin, Transcutaneous pCO2 Instrument for the indirect measurement of pCO2 partial MDC_DEV_CO2_TCUT
1::5160
surface | pressure on the surface of the skin.
Analyzer | Concentration | Airway, O2 | O2 gas analyzer Instrument for the direct measurement of airway O2 MDC_DEV_O2
1::5164
concentration and respiration rate.
Device | Concentration or Continuous O2 Instrument for the direct and continuous measurement MDC_DEV_O2_CTS
PartialPressure, O2 | Continuous | of O2 concentration or partial pressure. 1::5168

ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
IEEE Std 11073-10101a-2015
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